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Computer-assisted Cognitive Stimulation Treatment for Delirium (Delitract)

24. april 2026 opdateret af: Institut Investigacio Sanitaria Pere Virgili

Clinical, Demographic and Genetic Factors Associated With Response to Computer-assisted Cognitive Stimulation Treatment as Part of Non-pharmacological Care in Patients With Delirium. Feasibility Study.

The objectives of our study are to determine whether people with delirium in a subacute care unit improve after one week with non-pharmacological therapies based on improving sleep schedules, mobility, and cognitive stimulation (such as memory, attention, orientation, among others), and to compare two groups of people who will receive slightly different therapies.

We will try to determine whether individual characteristics (such as diagnosed diseases, blood test results or genetics, gender, age, educational level, among others) influence the onset of an episode of delirium, its severity and its response to treatment.

Participants with delirium will be divided into two groups that will receive:

  • The non-pharmacological treatment described
  • One group will also receive a specific cognitive intervention from an occupational therapist, using a computer programme on a tablet, twice a day for one week.

After one week, the presence and severity of delirium will be reassessed.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Spanien
    • Tarragona
      • Reus, Tarragona, Spanien, 43206
        • Rekruttering
        • Institut Pere Mata
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • All patients aged 60 years or over who are admitted to the subacute care center between 15 February and 15 October 2026 and who sign the informed consent (the patient and their family or legal guardians if the patient's cognitive condition prevents them from giving consent themselves)

Exclusion Criteria:

  • Patients who, at the time of admission, meet the criteria for palliative end-of-life care.
  • Individuals under 60 years of age, to ensure sample homogeneity and reduce confounding factors.
  • Individuals with severe visual or hearing impairment or aphasia, due to the difficulty of carrying out the cognitive intervention.
  • Serious communication difficulties due to language.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Computer-based cognitive intervention
Participants in this group will receive, in addition to standard non-pharmacological measures, a cognitive intervention using a tablet.
Adfærdsmæssigt: Specific computer-based cognitive stimulation intervention
Specific cognitive stimulation intervention using a tablet, administered by the occupational therapist, with the aim of carrying out two interventions each day: one in the morning and one in the afternoon. Each intervention will vary in duration, depending on the person's clinical condition, but will not exceed 20 minutes. Each person will receive the intervention for a period of one week from the diagnosis of delirium, corresponding to five working days. The intervention will focus on three cognitive aspects that are part of the core symptoms of delirium: attention, orientation and visuospatial ability.
Adfærdsmæssigt: Usual care intervention

Participants will undergo a comprehensive geriatric assessment and will be prescribed multidisciplinary treatment according to the clinical criteria of the centre's professionals, in order to address the underlying condition for which the patient has been admitted to the centre and any associated comorbidities. The guidelines for pharmacological and non-pharmacological treatment of delirium included in the centre's clinical guidelines will be followed.

With regard to the non-pharmacological treatment of delirium, specific measures will be taken for:

  1. Orientation and cognitive stimulation, including visuospatial measures.
  2. Early active mobility.
  3. Restoration of the sleep-wake cycle.
Aktiv komparator: Usual care intervention
Participants will receive the usual non-pharmacological measures, with emphasis on three groups: guidance, cognitive stimulation and visuospatial measures, early active mobility, and recovery of the sleep-wake cycle.
Adfærdsmæssigt: Usual care intervention

Participants will undergo a comprehensive geriatric assessment and will be prescribed multidisciplinary treatment according to the clinical criteria of the centre's professionals, in order to address the underlying condition for which the patient has been admitted to the centre and any associated comorbidities. The guidelines for pharmacological and non-pharmacological treatment of delirium included in the centre's clinical guidelines will be followed.

With regard to the non-pharmacological treatment of delirium, specific measures will be taken for:

  1. Orientation and cognitive stimulation, including visuospatial measures.
  2. Early active mobility.
  3. Restoration of the sleep-wake cycle.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Clinical changes in delirium
Tidsramme: Baseline and one week after enrollment
The overall severity of delirium and of each of its symptoms will be assessed using the Delirium Rating Scale-Revised-98 (DRS-98) by psychiatrists at the time of admission and after one week, in order to determine changes in its clinical manifestations. The DRS-98 includes phenomenological descriptors to assess the severity levels of each of its 16 items (ranging from 0 to 3, indicating from absence to maximum severity). Scores on the total scale range from 0 to 46 points (items 1 to 16) and from 0 to 39 points on the severity scale (items 1 to 13), indicating from the absence to the maximum severity of symptoms.
Baseline and one week after enrollment
The presence and severity of delirium and its core symptoms
Tidsramme: Baseline and one week after enrollment
The presence and severity of global delirium and of three of its symptoms corresponding to its core domains, assessed using the Delirium Diagnostic Tool-Provisional (DTT-Pro) administered by general practitioners at the time of admission and one week later, in order to determine changes in clinical manifestations. Each item is scored on a Likert scale ranging from zero (maximum severity) to three (no abnormality), with nine being the highest possible score and zero the lowest possible score. The recommended cut-off score is ≤6 for delirium and ≤7 to also identify patients with subsyndromic delirium.
Baseline and one week after enrollment
Presence of delirium according DSM-5 criteria
Tidsramme: One week after enrollment
Psychiatrists will assess for the presence of delirium according to the DSM-5 criteria at the time of admission and one week later, in order to determine whether the diagnosis still applies after one week.
One week after enrollment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Psychopharmacological treatment during the first week
Tidsramme: From enrollment to the end of the intervention in one week
We will record whether the individual has been prescribed any of the following types of medication: antipsychotics, benzodiazepines, anticholinergics, opioids and antidepressants. We will note whether these were prescribed on admission, during the follow-up period or at the end of the follow-up period. We will record the generic name and daily dose of each medication, in accordance with the internationally accepted units of measurement for each medication.
From enrollment to the end of the intervention in one week
Changes in functional independence in activities of daily living
Tidsramme: Upon enrollment and one week later
Functional independence in activities of daily living will be assessed on admission and one week later, using the Barthel Index. The Barthel Index uses a rating scale to score performance across 10 aspects, with total scores ranging from 0 to 100. A higher score indicates greater independence.
Upon enrollment and one week later
Change in fall risk
Tidsramme: Upon enrollment and one week later
The fall risk will be assessed on admission and one week later using the Tinetti test, which has a minimum score of 0 and a maximum score of 28 (the lower the score, the higher the fall risk).
Upon enrollment and one week later
Change in ability to walk unassisted
Tidsramme: Upon enrollment and one week later
The patient's walking ability prior to the acute episode that led to admission will be assessed on admission and again one week later using the Functional Ambulation Category (FAC) scale, where a score of 5 indicates the ability to walk unaided and a score of 0 indicates an inability to walk.
Upon enrollment and one week later
Relevant clinical events
Tidsramme: From admission to the first week
We will record clinical events such as the need for referral to A&E, death, falls, the use of physical restraints, new diagnoses or other significant occurrences. These will be recorded in free text format for subsequent classification.
From admission to the first week
Adherence to and follow-up of non-pharmacological measures
Tidsramme: From admission to the first week
We will assess participants' ability and willingness to adhere to non-pharmacological measures, both specific cognitive ones and general ones. These will be recorded in an open-ended format for subsequent classification.
From admission to the first week

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Institut Investigacio Sanitaria Pere Virgili

Samarbejdspartnere

Institut Pere Mata

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

16. februar 2026

Primær færdiggørelse (Anslået)

16. oktober 2026

Studieafslutning (Anslået)

16. februar 2027

Datoer for studieregistrering

Først indsendt

5. marts 2026

Først indsendt, der opfyldte QC-kriterier

24. april 2026

Først opslået (Faktiske)

1. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. april 2026

Sidst verificeret

1. februar 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Delitract

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Data will be made available on request.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF

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